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Gastric or Gastroesophageal Junction(GEJ) AdenocarcinomaPhase 2NCT04309578

A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC

A Phase 2 study testing Trastuzumab, Capecitabine and Cisplatin in people with Gastric or Gastroesophageal Junction(GEJ) Adenocarcinoma, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Trastuzumab, Capecitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
12 Mar 2020to 13 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with inoperable, locally-advanced or recurrent and/or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are not eligible for curative therapy and are histologically diagnosed.
  • Diseases measurable according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) using imaging technique (CT or MRI).
  • Tissue HER2-negative tumors (primary or metastatic tumors) defined as IHC2+ and FISH- or IHC 0 or 1+ according to gastric cancer assessment system for HER2 (see Annex 12.5).
  • ECOG Performance status 0, 1 or 2 (see Annex 12.1).
  • Survival for at least 3 months should be possible.
  • Appropriate bone marrow, renal, and hepatic functions. General inclusion criteria
  • Males or females aged 19 years.
  • Patients should sign the informed consent form (ICF).

Who cannot join

  • Patients who previously received chemotherapy for advanced/metastatic diseases (adjuvant/neoadjuvant chemotherapy, completed at least 6 months prior to enrollment in this clinical study, is permitted, but platinum-based adjuvant/neoadjuvant chemotherapy is not permitted).
  • Patients with a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome (e.g., patients who underwent partial or total gastric resection can participate in this clinical study, but patients equipped with a jejunostomy tube cannot participate).
  • Patients with active (serious or uncontrolled) gastrointestinal bleeding.
  • Patients with relevant toxicities remaining following previous curative therapy (except for alopecia). For example, neurotoxicity ≥ grade 2 based on NCI-CTCAE version 5.0.
  • Patients with a history of other malignant diseases based on the date of complete recovery within 5 years prior to the initiation of treatment in this clinical study (except for in-situ cervical cancer and basal cell carcinoma).
  • Hematologic, blood chemistry, and organ functions
Show all 25Show fewer
  • Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.
  • Serum bilirubin> 1.5 × upper limit of normal (ULN); or AST or ALT > 2.5 × ULN (or > 5 × ULN hepatic metastasis patients); or alkaline phosphatase > 2.5 × ULN (or > 5 × ULN hepatic metastasis patients, or > 10 × ULN hepatic metastasis-free bone metastasis patients); or, albumin < 2.5 g/dL.
  • Creatinine clearance < 60 mL/min. However, creatinine clearance is first calculated using the Cockroft-Gault formula, and if the value is < 60ml/min, a 24hr urine collection test is carried out. Subject enrollment is possible only when creatinine clearance is ≥ 60mL/min.
  • Other investigational product-associated exclusion criteria
  • History of proven congestive heart failure; angina pectoris in need of medication; evidence of transmural myocardial infarction through electrocardiogram (ECG); uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); clinically significant heart valve disorders; and high-risk uncontrolled arrhythmia.
  • Baseline left ventricular ejection fraction (LVEF) < 50% (measured with echocardiogram or MUGA).
  • Patients with dyspnoea at rest due to advanced tumors or other diseases, or who need an adjuvant oxygen therapy.
  • Patients who are treated with long-term or high-dose corticosteroids (steroid inhalation or short-term use of oral steroids for vomiting inhibition and appetite stimulation is permitted).
  • Patients with Clinically significant hypoacusis
  • Patients known to show dihydropyrimidine dehydrogenase (DPD) deficiency. General exclusion criteria
  • Patients with a history of brain metastasis or clinical evidence.
  • Uncontrolled serious systemic intercurrent diseases (e.g., infection or uncontrolled diabetes).
  • Females who are pregnant or are breast-feeding.
  • Fertile males and females who are unwilling to use effective contraceptive methods.
  • Patients who are treated with another investigational product within 4 weeks prior to the initiation of treatment in this clinical study.
  • Patients receiving radiation therapy within 4 weeks prior to the initiation of treatment with the study drug (palliative radiation curative therapy that is partially carried out for bone metastasis. Washout period of 2 weeks is also permitted in patients recovered from all acute toxicities.).
  • Patients who underwent major surgery within 4 weeks prior to the initiation of treatment with the study drug and have not yet been completely recovered.
  • Patients known to have HIV infectivity or active infection with HBV or HCV.
  • Patients with hypersensitivity to the study drug.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, Seoul

Other trials in South Korea

About this study

Official title: A Phase II Clinical Study of Trastuzumab in Combination With Capecitabine and Cisplatin (XP) in Patients With Tissue HER2-negative But Serum HER2-positive Advanced Gastric Cancer: XP+Samfenet

A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer

Read the detailed description

3-weekly/ 1cycle treatment

  • Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks
  • Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
  • Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1
Being tested
Trastuzumab, Capecitabine and Cisplatin
Medical subject headings
Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab, Capecitabine and CisplatinDrug

    • Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks
    • Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
    • Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1
Study groups in NCT04309578
Study groupRoleWhat they receive
treatment armExperimentalSingle arm
Receives: Drug: Trastuzumab, Capecitabine and Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy (Overall tumor response)

    Overall tumor response (responder/non-responder) which is a primary efficacy endpoint: is defined as the maximal response among confirmed cases of complete response (CR) or partial response (PR) determined by definite radiological assessment of target and nontarget lesions in accordance with RECIST criteria version 1.1.

    Measured: 2 years

Secondary outcomes (5)

  1. progression free survival

    Time from the start date of chemotherapy to the date of disease progression or death of any cause which comes first

    Measured: 2 years

  2. Duration of response

    Time from the date of tumor response by RECIST version 1.1 to the date of disease progression

    Measured: 2 years

  3. Overall Survival

    Time from the start date of chemotherapy to the date of death of any cause

    Measured: 2 years

  4. Time to disease progression

    Time from the start date of chemotherapy to the date of disease progression

    Measured: 2 years

  5. Safety(Toxicity profile)

    Assessed by NCI CTCAE version 5.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start12 Mar 2020
  3. Primary completion9 Jul 2024
  4. Study completion13 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309578
Sponsor's protocol ID
AMC2002
Status last verified
Apr 2026
First submitted
6 Jan 2020
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, Capecitabine and Cisplatin in people with Gastric or Gastroesophageal Junction(GEJ) Adenocarcinoma, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (Overall tumor response) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04309578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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